The Senior Product Development Engineer is a high-performing individual that will design and develop medical devices from concept through market introduction on a contract basis for client companies. The desired individual will possess a broad range of medical device design and development skills and experience, as well as depth of knowledge in several clinical, product and technical areas. The ideal candidate is a self-motivated individual who is excited by the prospect of working in a dynamic, entrepreneurial environment.
ESSENTIAL JOB DUTIES & RESPONSIBILITIES
- Develops new concepts from initial design to market release
- Investigates and evaluates existing technology
- Designs and implements new methodologies, materials, machines, processes or products to bring concept to market, including essential product and process documentation.
- Participates in the organization and execution of interdepartmental activities to ensure the completion of projects on schedule and within budget constraints. Conducts feasibility studies of the design to determine ability to function as intended.
- Maintains detailed documentation throughout all phases of research and development.
- Prepare project plans that specify project phases, tasks, task interdependencies, durations, resource assignments, and costs. Conduct risk analysis for products under development.
- Interacts with customer and supplier companies in a professional manner; proactively communicates with them to ensure an ongoing two-way exchange of information. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.
- Partners with Program Managers and technical staff to generate and develop concepts, prototypes and developed products / processes for new medical devices.
- Line management of junior resources. Ensures that all direct reports are efficiently utilized and billable at target levels, and assists in the development and mentoring of direct reports.
- Participates in brainstorming and design reviews. Maintains standards of excellence in all Product Development processes. Generates innovative concepts for new medical device designs to satisfy clinical requirements and meet or exceed customer expectations.
- All other duties as assigned
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor's degree in Mechanical, Biomedical Engineering or related discipline is required
- Minimum of 5 years of medical device design and development experience is required
SKILLS & ABILITIES
- Familiarity with design for manufacturability is desired
- SolidWorks 3D CAD proficiency
- Knowledge of probability and statistics
- Familiarity with FDA QSR and ISO 13,485 medical device regulations
- Depth of knowledge in one or more clinical areas
- Depth of knowledge in one or more product areas
- Depth of knowledge in one or more technical areas, for example, finite element analysis
- Demonstrated ability to bring products from concept to market
- Ability to interact with client companies in a professional manner
- Efficiency in the management of resources
- Customer focus with excellent communication skills, written and oral
- Flexibility, persistence, resourcefulness, a drive to succeed, and an entrepreneurial spirit